Health Services Management, Inc. Corporate Integrity …Health Services Management, Inc. (HSM)...

46
CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND HEALTH SERVICES MANAGEMENT, INC. I. PREAMBLE Health Services Management, Inc. (HSM) hereby enters into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (IUIS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(t)) (Federal health care program requirements). Contemporaneously with this CIA, HSM is entering into a Settlement Agreement with the United States. II. TERM AND SCOPE OF THE CIA A. The period of the compliance obligations assumed by HSM under this CIA shall be five years from the effective date of this CIA. The "Effective Date" shall be the date on which the final signatory of this CIA executes this CIA. Each one-year period, beginning with the one-year period following the Effective Date, shall be referred to as a "Reporting Period." B. This CIA applies to any Texas long term care facility in which HSM and/or an HSM subsidiary has an ownership or control interest, as defined in 42 U.S.C. § 1320a-3{a)(3), and any Texas long term care facility managed or operated by HSM and/or an HSM subsidiary. C. Sections VII, X, and XI shall expire no later than 120 days after OIG's receipt of: (1) HSM's final Annual Report; or (2) any additional materials submitted by HSM pursuant to OIG's request, whichever is later. D. For purposes of this CIA, the term "Covered Persons" includes: I. all owners, officers, directors, and employees ofHSM; HSMCIA

Transcript of Health Services Management, Inc. Corporate Integrity …Health Services Management, Inc. (HSM)...

  • CORPORATE INTEGRITY AGREEMENT

    BETWEEN THE

    OFFICE OF INSPECTOR GENERAL

    OF THE

    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    AND

    HEALTH SERVICES MANAGEMENT, INC.

    I. PREAMBLE

    Health Services Management, Inc. (HSM) hereby enters into this Corporate Integrity Agreement (CIA) with the Office ofInspector General (OIG) of the United States Department ofHealth and Human Services (IUIS) to promote compliance with the statutes, regulations, and written directives ofMedicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(t)) (Federal health care program requirements). Contemporaneously with this CIA, HSM is entering into a Settlement Agreement with the United States.

    II. TERM AND SCOPE OF THE CIA

    A. The period of the compliance obligations assumed by HSM under this CIA shall be five years from the effective date of this CIA. The "Effective Date" shall be the date on which the final signatory of this CIA executes this CIA. Each one-year period, beginning with the one-year period following the Effective Date, shall be referred to as a "Reporting Period."

    B. This CIA applies to any Texas long term care facility in which HSM and/or an HSM subsidiary has an ownership or control interest, as defined in 42 U.S.C. § 1320a-3{a)(3), and any Texas long term care facility managed or operated by HSM and/or an HSM subsidiary.

    C. Sections VII, X, and XI shall expire no later than 120 days after OIG's receipt of: (1) HSM's final Annual Report; or (2) any additional materials submitted by HSM pursuant to OIG's request, whichever is later.

    D. For purposes of this CIA, the term "Covered Persons" includes:

    I. all owners, officers, directors, and employees ofHSM;

    HSMCIA

  • 2. all owners, officers, directors, and employees ofany Texas long term care facility in which HSM and/or an HSM subsidiary has an ownership or control interest, as defined in 42 U.S.C. § 1320a-3(a)(3), and ofany Texas long term care facility managed or operated by HSM and/or an HSM subsidiary at any time during the term of the CIA; and

    3. all contractors, subcontractors, agents, and other persons who: (1) are involved directly or indirectly in the delivery ofresident care; (2) make assessments of residents that affect treatment decisions or reimbursement; (3) · perform billing, coding, audit, or review functions; ( 4) make decisions or provide oversight about staffing, resident care, reimbursement, policies and procedures, or this CIA; or (5) perform any function that relates to or is covered by this CIA, including individuals who are responsible for quality assurance, setting policies or procedures, or making staffmg decisi9ns.

    Any nonemployee private caregivers and/or attending physicians hired by any resident or the family or friends ofany resident ofHSM are not Covered Persons, regardless of the hours worked per year in HSM.

    ill. CORPORATE INTEGRITY OBLIGATIONS .

    HSM shall establish and maintain a Compliance Program that includes the following elements:

    A. Compliance Officer and Committee. Board ofDirectors. and Management Compliance Obligations

    1. Compliance Officer. Within 90 days after the Effective Date, HSM shall appoint a Compliance Officer and shall maintain a Compliance Officer for the term ofthe CIA. The Compliance Officer must have sufficient compliance and quality assurance experience to effectively oversee the implementation of the requirements ofthis CIA. The Compliance Officer shall be an employee and a member of senior management ofHSM, shall report directly to the Chief Executive Officer ofHSM, and shall not be or be subordinate to the General Counsel, ChiefFinancial Officer, or Chief Operating Officer, or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for HSM The Compliance Officer shall be responsible for, without limitation:

    2 HSMCIA

  • a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and professionally recognized standards ofcare;

    b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board ofDirectors of HSM, and shall be authorized to report on such matters to the Board ofDirectors at any time. Written documentation of the Compliance Officer's reports to the Board ofDirectors shall be made available to OIG upon request; and

    c. monitoring the day-to-day compliance activities engaged in by HSM and any reporting obligations created under this CIA, and ensuring that HSM is appropriately identifying and correcting quality ofcare problems.

    Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer's ability to perform the duties outlined in this CIA.

    HSM shall report to OIG, in writing, any changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer's ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.

    2. Compliance Committee. Within 90 days after the Effective Date, HSM shall appoint a Compliance Committee.

    a. General Responsibilities. This committee shall support the Compliance Officer in fulfilling his/her responsibilities ~ developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and professionally recognized standards ofcare; monitoring the day-to-day compliance activities engaged in by HSM; monitoring any reporting obligations created under this CIA; and ensuring that

    3 HSMCIA

  • HSM is appropriately identifying and correcting quality ofcare problems). The Compliance Committee shall, at a minimum, include the Compliance Officer and other members of senior management necessary to meet the requirements of this CIA( e.g., representatives from among senior personnel responsible for clinical operations and quality ofcare, human resources, operations). The Compliance Officer shall chair the Compliance Committee.

    The Compliance Committee shall meet, at a minimum, every month. The minutes of the Compliance Committee meetings shall be made available to the OIG upon request.

    HSM shall report to OIG, in writing, any actions or changes that would affect the Compliance Committee's ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.

    . b. Staffing Responsibilities. The Compliance Committee shall assess HSM's nursing staffing and make recommendations regarding how to improve such staffmg. The Compliance Committee shall consult with nurse managers, registered nurses (RNs), licensed practical nurses (LPNs), and certified nursing aides (CNAs) from each facility and the Independent Monitor required under Section ID.D ofthis CIA regarding staffmg at each facility. The Compliance Committee shall:

    I. review the development and implementation of the staffmg-related policies and procedures required by Section ill.B of this CIA.

    ii. assess, on an on-going basis, whether HSM is providing the quantity, quality, and composition ofnursing staffnecessary to meet residents'

    4 HSMCIA

  • needs at each of it~ facilities;

    c.

    d.

    iii. make recommendations as to how HSM can improve the quantity, quality, and composition of nursing staffnecessary to meet residents' needs;

    iv. identify obstacles related to the recruitment, retention, and training of nursing staff at each of HSM's facilities; and

    v. make recommendations as to how HSM can improve the recruitment, retention, and training ofnursing staff.

    Quality ofCare Review Program. The Compliance Committee shall ensure that, within 120 days after the Effective Date, HSM establishes and implements a program for performing internal quality audits and reviews (hereinafter "Quality of Care Review Program"). The Quality ofCare Review Program shall make findings as to:

    1. whether the residents at HSM are receiving the quality ofcare consistent with professionally recognized standards of care, 42 C.F.R. Part 483, and any other applicable federal and state statutes, regulations, and directives;

    ii. whether HSM is effectively reviewing quality of care related incidents and completing root cause analyses; and

    iii. whether HSM's action plans in response to identified quality ofcare problems are appropriate, timely, implemented, and enforced.

    Qualityo/Care Dashboard. The Compliance Committee, in consultation with the Monitor required under Section III.D of this CIA, shall create and

    5 HSMCJA

  • implement a "Quality of Care Dashboard" (Dashboard), which will function as a performance scorecard for HSM. Quality indicator data shall be collected and reported on the Dashboard. Within 120 days after the Effective Date, the Compliance Committee shall: (1) identify and establish the overall quality improvement goals for HSM based on its assessment ofHSM~s quality of care risk areas; (2) identify and establish the quality indicators related to those goals that HSM will monitor through the Dashboard; and (3) establish performance metrics for each quality indicator. The Compliance Committee shall measure, analyze, and track the performance metrics for the quality indicators on a monthly basis, monitoring progress towards the quality improvement goals. At least semi-annually, the Compliance Committee shall review the quality indicators to determine if revisions are appropriate and shall make any necessary revisions based on such review.

    3. Board ofDirectors Compliance Obligations. The Board of Directors (or a committee ofthe Board) ofHSM (Board) shall be responsible for the review and oversight ofmatters related to compliance with the requirements and obligations of this CIA, Federal health care program requirements, and professionally recognized standards ofcare. The Board must include independent (i.e., non-executive) members. The Board shall be readily available to the Compliance Officer and the Monitor required under Section ill.D of this CIA to respond to any issues or questions that might arise.

    The Board shall, at a minimum, be responsible for the following:

    a. meeting at least quarterly to review and oversee HSM' s compliance program, including, but not limited to, the performance of the Compliance Officer and the Compliance Committee;

    b. reviewing the adequacy ofHSM's system of internal controls, quality assurance monitoring, and resident care;

    6

    HSMCIA

  • c. ensuring that HSM's response to state, federal, internal, and external reports of quality ofcare problems is complete, thorough, and resolves the problem(s) identified;

    d. ensuring that HSM adopts ~d implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and profes~ionally recognized standards ofcare;

    e. reviewing and responding to the Dashboard and ensuring that HSM implements effective responses when potential quality problems are indicated on the Dashboard or when quality indicators show that HSM is not meeting its established goals; and

    f. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of HSM; s compliance with the obligations of this CIA, Federal health care program requirements, and professionally recognized standards ofcare.

    At a minimum, the resolution shall include the following language:

    "The Board ofDirectors has made a reasonable inquiry into the operations ofHSM's Compliance Program, including the performance of the Compliance Officer and the Compliance Committee. The Board has also provided oversight on quality of care issues. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, HSM has implemented an effective Compliance Program to meet the obligations of the CIA, Federal health care program requirements, and professionally recognized standards of care."

    7 HSMCIA

  • Ifthe Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at HSM.

    HSM shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ability to perfonn the duties necessary to meet the obligations in this CIA, within 15 days after such a change.

    4. Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain HSM employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable HSM department is in compliance with applicable Federal health care program requirements, with the obligations of this CIA, and with professionally recognized standards of healthcare. These Certifying Employees shall include, at a minimum, the following: all members of senior management and the leaders ofall Texas subsidiaries with operations that relate to the federal health care programs. For each Reporting Period, each Certifying Employee shall sign a certification that states:

    "I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name ofdepartment], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name ofdepartment] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, professionally recognized standards ofhealthcare, and HSM policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] ofHSM is in compliance with all applicable Federal health care program requirements, the obligations of the Corporate Integrity Agreement, and professionally recognized standards ofhealthcare. I understand that this certification is being provided to and relied upon by the United States."

    Ifany Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

    8 HSMCIA

  • B. Written Standards

    Policies and Procedures. Within 90 days after the Effective Date, HSM shall develop and implement written Policies and Procedures regarding the operation ofHSM's compliance program, including the compliance program requirements outlined in this CIA and HSM's compliance with Federal health care program requirements and professionally recognized standards of care (Policies and Procedures). Throughout the term ofthis CIA, Provider shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance ofall employees.

    At a minimum, the Policies and Procedures shall:

    a. the compliance program requirements outlined in this ·CIA;

    b. the requirements applicable to Medicare's Prospective Payment System (PPS) for skilled nursing facilities, including, but not limited to: ensuring the accuracy of the clinical data required under the Minimum Data Set (MDS) as specified by the Resident Assessment Instrument User's Manual; ensuring that HSM is appropriately and accurately using the current Resource Utilization Groups (RUG) classification system; and ensuring the.accuracy ofbilling and cost report preparation policies and procedures;

    c. compliance with the completion ofaccurate clinical assessments as required by applicable Federal law, which shall include: (1) that all resident care information be recorded in ink or permanent print; (2) that corrections shall only be made in accordance with accepted health information management standards; (3) that erasures shall not be allowable; and (4) that clinical records may not be rewritten or destroyed to hide or otheiwise make a prior entry unreadable or inaccessible;

    d. compliance with Titles XVIII and XIX of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk-1and1396

    9 HSMCIA

  • e.

    f.

    1396w-5, and all regulations, directives, and guidelines promulgated pursuant to these statutes, including, but not limited to, 42 C.F.R. Parts 424 and 483, and any other state or local statutes, regulations, directives, or guidelines that address quality of care in nursing homes, as well as professionally recognized standards ofhealth care;

    the coordinated interdisciplinary approach to providing care, including but not limited to the following areas addressed in 42 C.F.R. § 483:

    1. resident rights; ii. admission, transfer, and discharge rights; iii. resident behavior and facility practices; iv. quality of life; v. resident assessment; vi. quality ofcare; vii. nursing services; viii. dietary services; ix. physician services; x. specialized rehabilitative services; xi. dental services; xii. pharmacy services; xiii. infection control; xiv. physical environment; and xv. administration.

    staffing, including but not limited to:

    i. ensuring that nursing staff levels are sufficient to meet residents' needs, as required by Federal and state laws, including but not limited to 42 C.F.R. § 483.30 (nursing services);

    ii. a measurable, acuity-based staffmg protocol that includes resident needs-based direct care nurse staffmg per patient day scaled requirements for each class ofnursing staff ~. RNs, LPNs, CNAs) and the methodology

    10 HSMCIA

  • for establishing the per patient day requirements;

    111. ensuring that Covered Persons are informed of the staffing requirements ofFederal and state law, that staffmg levels are a critical aspect of resident care, and that, if any person has a concern about the level of staffmg, there are m~y avenues available to report such concerns, including but not limited to the Administrator, the Disclosure Program (as described in Section III.E of this CIA), appropriate corporate officials, or directly to the Compliance Officer or Monitor; and

    iv. minimizing the number of individuals working on a temporary assignment or not employed by HSM (not in(!luding those persons who are included in the defmition ofCovered Persons) and creating and maintaining a standardized system to track the number of individuals who fall within this category so that the number/proportion ofor changing trends in such staff can be adequately identified by HSM or the Monitor. ·

    g. capital improvements, including but not limited to a process to ensure that HSM and its nursing facilities address facility maintenance and repairs: equipment adequacy, supplies, and make necessary capital expenditures to provide a habitable environment and to protect the health and safety of residents, personnel, and the public in a timely manner consistent with their obligations under the Nursing Home Reform Act, OBRA 1.987, Pub. L. 100-203 § 4203 (amending Social Security Act§ 1818(g), (h)), and its regulations.

    The Policies and Procedures shall be made available to all Covered Persons.

    11 HSMCIA

  • At least annually (and more frequently, if appropriate), HSM shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons.

    All Policies and Procedures shall be made available to OIG upon request.

    C. Training and Education

    1. Covered Persons Training. Within 90 days after the Effective Date, HSM shall develop a written plan (Training Plan) that outlines the steps HSM will take to ensure that all Covered Persons receive (a) at least annual training regarding HSM's CIA requirements and Compliance Program, and (b) adequate on-going training regarding: (i) policies, procedures, and other requirements applicable to the documentation of medical records; (ii) the policies implemented pursuant to Section III.B of this CIA, as appropriate for the job category ofeach Covered Person; {iii) the coordinated interdisciplinary approach to providing care and related communication between disciplines; (iv) the personal obligation ofeach individual involved in resident care to ensure that care is appropriate and meets professionally recognized standards ofcare; (v) examples of proper and improper care; and (vi) reporting requirements and legal sanctions for violations ofthe Federal health care program requirements. The Training Plan shall also include training to address quality of care problems identified by the Compliance Committee. In determining what training should be performed, the Compliance.Committee shall review the complaints received, satisfaction surveys, staff turnover data, any state or federal surveys, including those performed by CMS survey and its agents the Joint Commission or other such private agencies, any internal surveys, the CMS quality indicators, and the findings, reports, and recommendations of the Monitor required under Section m.D of this CIA.

    Training required in this section shall be competency-based. Specifically, the training must be developed and provided in such a way as to focus on Covered Persons achieving learning outcomes to a specified competency and to place emphasis on what a Covered Persori has learned as a result of the training.

    2. Board Member Training. Within 90 days after the Effective Date, each member of the Board ofDirectors shall receive at least two hours of . training. This training shall address the corporate governance r~sponsibilities of board members, and the responsibilities ofboard members with respect to review and oversight of the Compliance Program. Specifically, the training shall address the unique responsibilities ofhealth care Board members, including the risks,

    12 HSMCIA

  • oversight areas, and strategic approaches to conducting oversight ofa health care entity. This training may be conducted by an outside compliance expert hired by the Board and should include a discussion of the OIG's guidance on Board member responsibilities.

    New members of the Board of Directors shall receive the Board Member

    Training described above within 30 days after becoming a member or within 90

    days after the Effective Date, whichever is later.

    3. Training Records. HSM shall make available to OIG, upon request, training materials and records verifying that Covered Persons and Board members have timely received the training required under this section.

    D. Independent Monitor

    Within 60 days after the Effective Date, HSM shall retain an appropriately qualified monitoring team (the "Monitor"), selected by OIG after consultation with HSM. The Monitor may retain additional personnel, including but not limited to independent consultants, ifneeded to help meet the Monitor's obligations under this CIA. The Monitor may confer and correspond with HSM or OIG individually or together. The Monitor and HSM shall not negotiate or enter into a financial relationship, other than the monitoring engagement required by this section, until after the date of OIG's CIA closure letter to HSM or six months after the expiration of this CIA, whichever is later.

    The Monitor is not an agent of OIG. However, the Monitor may be removed by OIG at its sole discretion. Ifthe Monitor resigns or is removed for any other reasons prior to the termination of the CIA, HSM shall retain, within 60 days of the resignation or removal, another Monitor selected by OIG, with the same functions and authorities.

    1. Scope ofReview. The Monitor shall be responsible for

    assessing the effectiveness, reliability, and thoroughness of the following:

    a. HSM's internal quality control systems, including but not limited to:

    i. whether the systems in place to promote quality ofcare and to respond to quality ofcare

    13 HSMCIA

  • problems are operating in ;:i. timely and effective manner;

    ii. whether the communication system is effective, allowing for accurate information, decisions, and results ofdecisions to be transmitted to the proper individuals in a timely fashion; and

    iii. whether the training programs are effective, thorough, and competency-based.

    b. HSM's response to quality of care issues, which shall include an assessment of:

    1. HSM's ability to identify the problem;

    ii. HSM's ability to determine the scope of the problem, including but not limited to whether the problem is isolated or systemic;

    iii. HSM' s ability to conduct a root cause analysis;

    1v. HSM's ability to create an action plan to respond to the problem;

    v. HSM's ability to execute the action plan; and

    vi. HSM's ability to monitor and evaluate whether the assessment, action plan, and execution of that plan was effective, reliable, and thorough.

    c. HSM's proactive steps to ensure that each resident receives care in accordance with:

    1. professionally recognized standards ofhealth care;

    ii. the rules and regulations set forth in 42 C.F.R Part 483;

    14 HSMCIA

  • m. State and local statutes, regulations, and other directives or guidelines; and

    iv. the Policies and Procedures adopted by HSM, including those implemented under Section IIl.B of this CIA;

    d. HSM's compliance with staffing requirements;

    e. HSM' s ability to analyze outcome measures, such as the CMS Quality Indicators, and other data;

    £ HSM' s Quality of Care Review Program required under Section ID.A.2.c of this CIA;

    g. HSM' s Quality of Care Dashboard required under Section IIl.A.2.d of this CIA; and

    h. HSM' s ability to identify and correct physical plant problems, including the implementation and effectiveness of the capital improvements process required under Section ID.B of this CIA.

    2. Access. The Monitor shall have:

    a. immediate access to HSM, at any time and without prior notice, to assess compliance with this CIA, to assess the effectiveness of the internal quality assurance mechanisms, and to ensure that the data being generated is accurate;

    b. immediate access to:

    i. the CMS quality indicators;

    ii. internal or external surveys or reports;

    111. Disclosure Program complaints;

    iv. resident satisfaction surveys;

    15 HSMCIA

  • v. staffing data in the format requested by the Monitor;

    vi. reports of abuse, neglect, or an incident that required hospitalization or emergency room treatment;

    vii. reports of any falls;

    viii. reports ofany incident involving a resident that prompts a full internal investigation;

    ix. resident records;

    x. documents in the possession or control ofany quality assurance committee, peer review committee, medical review committee, or other such committee; and

    xi. any other data in the format the Monitor determines relevant to fulfilling the duties required under this CIA;

    c. immediate access to residents, and Covered Persons for interviews outside the presence ofHSM supervisory staff or counsel, provided such interviews are conducted in accordance with all applicable laws and the rights ofsuch individuals. The Monitor shall give full consideration to an individual's clinical condition before interviewing a resident.

    3. Baseline Systems Assessment. Within 60 days after the Monitor is retained by HSM or 120 days after the Effective Date ofthe CIA, whichever is later, the Monitor shall:

    a. complete an assessment ofthe effectiveness, reliability, scope, and thoroughness ofthe systems described in Section ill.D.1;

    16 HSMCIA

  • b. in conducting this assessment, visit at least 4 of RSM's facilities (selected by the Monitor) and, at a minimum, observe quality assurance meetings, observe corporate compliance meetings, observe care planning meetings, interview key employees, review relevant documents, and observe resident care; and

    c. submit a written report to RSM and OIG that sets forth, at a minimum:

    i. a summary of the Monitor's activities in conducting the assessment;

    ii. the Monitor's findings regarding the effectiveness, reliability, scope, and thoroughness of each ofthe systems described in Section IIl.D .1; and

    m. the Monitor's recommendations to RSM as to how to improve the effectiveness, reliability, scope, and thoroughness ofthe systems described in Section 111.D.1.

    4. Systems Improvements Assessments. On a quarterly basis, the Monitor shall:

    a. re-assess the effectiveness, reliability, and thoroughness of the systems described in Section IIl.D.1;

    b. assess RSM's response to recommendations made in prior written assessment reports;

    c. in conducting these assessments, visit at least 4 of RSM's facilities (selected by the Monitor) and, at a minimum, observe quality assurance meetings, observe corporate compliance meetings, observe care planning meetings, interview key employees, review relevant documents, and observe resident care (the Monitor may also want to have regular telephone calls with

    17 HSMCJA

  • HSM and any of its poorer perfonning facilities); and

    b. submit a written report to HSM and OIG that sets forth, at a minimum:

    i. a summary of the Monitor's activities in conducting the assessment;

    ii. the Monitor's findings regarding the effectiveness, reliability, scope, and thoroughness of each of the systems described in Section Ill.D.l;

    iii. the Monitor's recommendations to HSM as to how to improve the effectiveness, reliability, scope, and thoroughness ofthe systems described in Section III.D. l; and

    iv. the Monitor's assessment ofHSM's response to the Monitor's prior recommendations.

    The Monitor shall perfonn assessments for each quarter after the Baseline Systems Assessment. The Monitor shall submit written reports no later than 30 days after the end of the relevant quarter to Provider and OIG.

    5. Financial Obligations ofHSM and the Monitor.

    a. HSM shall be responsible for all reasonable costs incurred by the Monitor in connection with this engagement, including but not limited to labor costs (direct and indirect); consultant and subcontract costs; materials cost (direct and indirect); and other direct costs (travel, other miscellaneous).

    b. HSM shall pay the Monitor's bills within 30 days of receipt. Failure to pay the Monitor within 30 calendar days of submission of the Monitor's invoice for services previously rendered shall constitute a basis to impose stipulated penalties or exclude HSM, as

    18 HSMCIA

  • provided under Section X ofthis CIA. While HSM must pay all ofthe Monitor's bills within 30 days, HSM may bring any disputed Monitor's Costs or bills to OIG's attention.

    c. The Monitor shall charge a reasonable amount for its fees and expenses, and shall submit monthly invoices to Provider with a reasonable level ofdetail reflecting all key category costs billed.

    d. The Monitor shall submit a written report for each Reporting Period representing an accounting of its costs throughout the year to HSM and to OIG by the submission deadline ofHSM's Annual Report. This report shall reflect, on a cumulative basis, all key category costs included on monthly invoices.

    6. Additional HSM Obligations. HSM shall:

    a. provide to the Monitor the ~S Quality Indicator data within five days after receipt ofa written request for that data from the Monitor;

    b. within 30 days after receipt ofeach written report of the Baseline Systems Assessment or Systems Improvement Assessments, submit a written response to OIG and the Monitor to each recommendation contained in those reports stating what action HSM took in response to each recommendation or why HSM has elected not to take action based on the recommendation;

    c. provide the Monitor a report monthly, or sooner if requested by the Monitor, regarding each of the following:

    i. Deaths or injuries related to use ofrestraints;

    ii. Deaths or injuries related to use ofpsychotropic medications;

    19 HSMCIA

  • d.

    e.

    f.

    iii. Suicides;

    iv. Deaths or injuries related to abuse or neglect (as defined in the applicable federal guidelines);

    v. Fires, stonn damage that poses a threat to residents or otherwise may disrupt the care provided, flooding, or major equipment failures atHSM;

    v1. Strikes or other work actions that could affect resident care;

    vii. Man-made disasters that pose a threat to residents ~ toxic waste spills); and

    viii. Any other incident that involves or causes actual hann to a resident when such incident is required to be reported to any local, state, or federal government agency.

    Each such report shall contain, ifapplicable, the full name, social security number, and date of birth of the residents(s) involved, the date ofdeath or incident, and a brief description of the events surrounding the death or incident.

    provide to its Compliance. Committee and Board of Directors Committee copies ofall documents and reports provided to the Monitor;

    ensure the Monitor's immediate access to the.facility, residents, Covered Persons, and documents, and assist in obtaining full cooperation by its current employees, contractors, and agents;

    provide access to current residen~s and provide contact infonnation for their families and guardians consistent with the rights-of such individuals under state or

    20 HSMCIA

  • federal law, and not impede their cooperation with the Monitor;

    g. · assist in locating and, if requested, attempt to obtain cooperation from past employees, contractors, agents, and residents and their families;

    h. provide the last known contact information for former residents, their families, or guardians consistent with the rights of such individuals under state or federal law, and not impede their cooperation; and

    i. not sue or otherwise bring any action against the Monitor related to any findings made by the Monitor or related to any exclusion or other sanction ofHSM under this CIA; provided, however, that this clause shall not apply to any suit or other action based solely on the dishonest or illegal acts of the Monitor, whether acting alone or in collusion with others.

    7. Additional Monitor Obligations. The Monitor shall:

    a. abide by all state and federal laws and regulations concerning the privacy, dignity, and employee rights of all Covered Persons, and residents;

    b. abide by the legal requirements of RSM to maintain the confidentiality ofeach resident's personal and clinical records'. Nothing in this subsection, however, shall limit or affect the Monitor's obligation to provide information, including information from resident clinical records, to OIG, and, when legally or professionally required, to other agencies;

    c. at all times act reasonably in connection with its duties under the CIA including when requesting information from RSM;

    d. if the Monitor has concerns about action plans that are not being enforced or systemic problems that could

    21 HSMCIA

  • e.

    f.

    affect HSM's ability to render quality care to its residents, then the Monitor shall:

    1. report such concerns in writing to OIG; and

    11. simultaneously provide notice and a copy of the report to HSM's Compliance Committee and Board ofDirectors Committee referred to in Section ill.A of this CIA;

    where independently required to do so by applicable . law or professional licensing standards, report any

    finding to an appropriate regulatory or law

    enforcement authority, and simultaneously submit

    copies of such reports to OIG and to HSM;

    not be bound by any other private or governmental agency's findings or conclusions, including, but not limited to, Joint Commission, CMS, or the state survey agency. Likewise, such private and governmental agencies shall not be bound by the Monitor's findings

    . or conclusions. The Monitor's reports shall not be the sole basis for determining deficiencies by the state survey agencies. The parties agree that CMS and its contractors shall not introduce any material generated by the Monitor, or any opinions, testimony, or conclusions from the Monitor as evidence into any proceeding involving a Medicare or Medicaid survey, certification, or other enforcement action against HSM, and HSM shall similarly be restricted from using material generated by the Monitor, or any opinions, testimony, or conclusions from the Monitor as evidence in any of these proceedings. Nothing in the previous sentence, however, shall preclude OIG or HSM from using any material generated by the Monitor, or any opinions, testimony, or conclusions from the Monitor in any action under the CIA or pursuant to any other OIG authorities or in any other situations not explicitly excluded in this subsection;

    22 HSMCIA

  • g. abide by the provisions of the Health Insurance Portability and Accountability Act (IIlPAA) of 1996 to the extent required by law including, without limitation, entering into a business associate agreement with HSM; and

    h. · except to the extent required. by law, maintain the confidentiality of any proprietary financial and operational information, processes, procedures, and forms obtained in connection with its duties under this CIA and not comment publicly concerning its findings except to the extent authorized by OIG.

    E. Disclosure Program

    Within 90 days after the Effective Date, HSM shall establish a Disclosure Program that includes a mechanism Ul.&. a toll-free compliance telephone line) to enable· individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual's chain ofcommand, any identified issues or questions associated with HSM's policies, conduct, practices, or procedures with respect to quality ofcare or a Federal health care program believed by the individual to be a potential violation ofcriminal, civil, or administrative law. HSM shall appropriately publicize the existence ofthe disclosure mechanism ~. via periodic e-mails to employees or by posting the information in prominent common areas).

    The Disclosure Program shall emphasize a nonretribution, nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all ofHSM' s Covered Persons shall be expected to report suspected violations ofany Federal health care program requirements to the Compliance Officer or other appropriate individual designated by HSM. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether. a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness ofthe alleged improper practice; and (2) provides an opportunity for taking corrective action, HSM shall

    23 HSMCIA

  • conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. Ifthe inappropriate or improper practices places residents at risk of hann, then HSM will ensure that that practice ceases immediately and that appropriate action is taken.

    The Compliance Officer (or designee) shall maintain a disclosure log and shall record each disclosure in the disclosure log within two business days of receipt ofthe.disclosure. The disclosure log shall iQ.clude a summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.

    The disclosure log shall be sent to the Monitor required under Section ill.D of this CIA not less than monthly.

    F. Ineligible Persons

    1. Definitions. For purposes of this CIA:

    a. an "Ineligible Person" shall include an individual or entity who:

    i. is currently excluded from participation in any Federal health care program; or

    u. has been convicted ofa criminal offense that falls within the scope of42 U.S.C. § 1320a7(a), but has not yet been excluded.

    b. "Exclusion List" means the IIBS/OIG List of Excluded Individuals/Entities (LEIB) (available through the Internet at http://www.oig.hhs.gov).

    2. Screening Requirements. HSM shall ensure that all prospective and current Covered Persons are not Ineligible Persons, by implementing the following screening requirements.

    a. HSM shall screen all prospective Covered Persons against the Exclusion List prior to engaging their

    24 HSMCIA

    http:http://www.oig.hhs.govhttp://www.oig.hhs.gov

  • services and, as part of the hiring or contracting process, shall require such Covered Persons to disclose whether they are Ineligible Persons.

    b. HSM shall screen all current Covered Persons against the Exclusion List within 90 days after the Effective Date and on a monthly basis thereafter.

    c. RSM shall implement a policy requiring all Covered Persons to disclose immediately if they become an Ineligible Person.

    Nothing in this Section ill.F affects RSM's responsibility to refrain from (and liability for) billing Federal health care programs for items or services furnished, ordered, or prescribed by an excluded person. RSM understands that items or services furnished, ordered, or prescribed by excluded persons are not payable by Federal health care programs and that RSM may be liable for overpayments and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless ofwhether HSM meets the requirements of Section III.F.

    3. Removal Requirement. lfHSM has actual notice that a Covered Person has become an Ineligible Person, HSM shall remove such Covered Person from responsibility for, or involvement with, HSM's business operations related to the Federal health care program(s) from which such Covered Person has been excluded and shall remove such Covered Person from any position for which the Covered Person's compensation or the items or services furnished, ordered, or prescribed by the Covered Person are paid in whole or part, directly or indir~ctly, by any Federal health care program(s) from which the Covered Person has been excluded at least until such time as the Covered Person is reinstated into participation in such Federal health care program(s).

    4. Pending Charges and Proposed Exclusions. lfRSM has actual notice that a Covered Person is charged with a criminal offense that falls within the scope of42 U.S.C. §§ 1320a-7(a), 1320a-7(b )(1)-(3), or is proposed for exclusion during the Covered Person's employment or contract term, HSM shall take all appropriate actions to ensure that the responsibilities of that Covered Person have not and shall not adversely affect the quality ofcare rendered to any beneficiary or the accuracy ofany claims submitted to any Federal health care program.

    25 HSMCIA

  • G. Notification ofGovernment Investigation or Legal Proceeding

    Within 30 days after discovery, HSM shall notify OIG, in writing, ofany ongoing investigation or legal proceeding known to HSM conducted or brought by a governmental entity or its agents involving an allegation that HSM has committed a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. HSM also shall provide written notice to OIG within 30 days after the resolution ofthe matter, and a description of the findings and/or results of the investigation or proceeding, ifany.

    In addition, within 15 days after notification, HSM shall notify OIG, in writing, ofany adverse final determination made by a federal, state, or local government agency or accrediting or certifying agency ~ Joint Commission) relating to quality ofcare issues.

    H. Over.payments

    1. Definition ofOverpayment. An "Overpayment" means any funds that HSM receives or retains under any Federal health care program to which HSM, after applicable reconciliation, is not entitled under such Federal health care program.

    2. Overpayment Policies andProcedur~s. Within 90 days after the Effective Date, HSM shall develop and implement written policies and procedures regarding the identificatfon, quantification; and repayment of Overpayments received from any Federal health care program.

    I. Reportable Events

    1. Definition ofReportable Event. For purposes ofthis CIA, a "Reportable Event" means anything that involves:

    a. a substantial Overpayment;

    b. a matter that a reasonable person would consider a probable violation ofcriminal, civil, or administrative

    26

    HSMCIA

  • laws applicable to any Federal health care program for which penalties or exclusion may be authorized;

    c. a violation ofthe obligation to provide items or services ofa quality that meets professionally recognized standards ofhealth care where such violation has occurred in one or more instances and presents an imminent danger to the health, safety, or well-being ofa Federal health care program beneficiary or places the beneficiary unnecessarily in high-risk situations;

    d. the employment ofor contracting with a Covered Person who is an Ineligible Person as defined by Section III.F. l .a; or

    e. insolvency, a matter that a reasonable person would consider likely to render HSM insolvent, or the filing ofa bankruptcy petition by HSM.

    A Reportable Event may be the result ofan isolated event or a series of occurrences.

    2. Reporting ofReportable Events. lfHSM det~nnines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, HSM shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists.

    3. Reportable Events under Section 111.1.1.a and 111.1.1.b. For Reportable Events under Section III.I. I .a and b, the report to OIG shall include:

    a. a complete description ofall details relevant to the Reportable Event, including, at a minimum, the types ofclaims, transactions or other conduct giving rise to the Reportable Event; the period during which the conduct occurred; and the names of individuals and entities believed to be implicated, including an explanation of their roles in the Reportable Event;

    27 HSMCIA

  • b. a statement of the Federal criminal, civil or administrative laws that are probably violated by the Reportable Event, if any;

    c. the Federal health care programs affected by the Reportable Event;

    d. a description of the steps taken by HSM to identify and quantify any Overpayments; and

    e. a description ofHSM's actions taken to correct the Reportable Event and prevent it from recurring.

    If the Reportable Event involves an Overpayment, within 60 days of identification of the Overpayment, HSM shall repay the Overpayment, in accordance with the requirements of42 U.S.C. § 1320a-7k(d) and42 C.F.R. § 401.301-305 (and any applicable CMS guidance) and provide OIG with a copy of the notification and repayment.

    4. Reportable Events under Section JILL i.e. For Reportable Events under Section III.1.1.c, the report to OIG shall include:

    a. a complete description of the Reportable Event, including the relevant facts, persons involved, the impact or potential impact on Federal health care program beneficiaries, and any legal and Federal health care program authorities implicated;

    b. a description ofHSM's action taken to correct the Reportable Event;

    c. any further steps HSM plans to take to address the Reportable Event and prevent it from reoccurring; and

    d. a summary ofany related reports made to Federal or state regulatory or enforcement agencies or to professional licensing bodies.

    5. Reportable Events under Section I!Lll.d. For Reportable Events under Section III.I.1.d, the report to OIG shall include:

    28 HSMCIA

  • a. the identity of the Ineligible Person and the job duties performed by that individual;

    b. the dates of the Ineligible Person's employment or contractual relationship;

    c. a description ofthe Exclusion List screening that HSM completed before and/or during the Ineligible Person's employment or contract and any flaw or breakdown in the screening process that led to the hiring or contracting with the Ineligible Person;

    d. a description ofhow the Ineligible Person was identified; and

    e. a description ofany corrective action implemented to prevent future employment or contracting with an Ineligible Person.

    6. Reportable Events under Section /ILL 1. e. For Reportable Events under Section ID.I. l .e, the report to OIG shall include:

    a. a complete description of the Reportable Event;

    b. a description ofHSM's action taken to ensure that the Reportable Event does not adversely impact resident care;

    c. any further steps HSM plans to take to address the Reportable Event; and

    d. if the Reportable Event involves the filing ofa bankruptcy petition, documentation of the bankruptcy filing and a description ofany Federal health care program requirements implicated.

    7. Reportable Events Involving the Stark Law. Notwithstanding the reporting requirements outlined above; any Reportable Event that involves solely a probable violation ofsection 1877 of the Social Security Act, 42 U.S.C. §1395nn (the Stark Law) should be submitted by HSM to the Centers for Medicare & Medicaid Services (CMS) through the self-referral disclosure protocol

    29 HSMCIA

  • (SRDP), with a copy to the OIG. IfHSM identifies a probable violation of the Stark Law and repays the applicable Overpayment directly to the CMS contractor, then HSM is not required by this Section III.I to submit the Reportable Event to CMS through the SRDP.

    IV. SUCCESSOR LIABILITY

    In the event that, after the Effective Date, HSM proposes to (a) sell any or all of its business, business units, or locations in Texas (whether through a sale of assets, sale of stock, or other type of transaction) relating to the furnishing of items or services that may be reimbursed by a Federal health care program, or (b) purchase or establish a new business, business unit, or location relating to the furnishing of items or services in Texas reimbursed by a Federal health care program, the CIA shall be binding on the purchaser of any business, business unit, or location and any new business, business unit, or location (and all Covered Persons at each new business, business unit, or location) shall be subject to the applicable requir~ments ofthis CIA, unless otherwise determined and agreed to in writing by OIG.

    If, in advance ofa proposed sale or a proposed purchase, HSM wishes to obtain a determination by OIG that the proposed purchaser or the proposed acquisition will not be subject to the requirements of the CIA, HSM must notify OIG in writing of the proposed sale or purchase at least 30 days in advance. This notification shall include a description of the business, business unit, or location to be sold or purchased, a briefdescription of the terms of the transaction and, in the case ofa proposed sale, the name and contact information of the prospective purchaser.

    V. IMPLEMENTATION AND ANNUAL REPORTS

    A. Implementation Report.

    Within 120 days after the Effective Date, HSM shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include:

    I. the name, address, phone number, and position description of the Compliance Officer required by Section Ill.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have;

    30 HSMCIA

  • 2. the names and positions of the members of the Compliance Committee required by Section III.A;

    3. the names of the Board members who are responsible for satisfying the Board Committee compliance obligations described in Section Ill.A;

    4. a description ofthe Quality of Care Review Program required by Section ill.A.2.c;

    5. a description ofthe Dashboard required by Section Ill.A.2.d;

    6. the names and positions ofthe Certifying Employees required by Section ill.A.4;

    7. a list of all Policies and Procedures required by Section ill.B.2;

    8. the Training Plan required by Section ill.C.1 and a description of the Board ofDirectors trainii:tg required by Section ill.C.2 (including a summary of the topics covered, the length of the training, and· when the training was provided);

    9. a description of the Disclosure Program required by Section ill.E;

    10. a description of the Ineligible Persons screening and removal process required by Section ill.F;

    11. copy ofHSM' s policies and procedures regarding the identification, quantification, and repayment ofOverpayments required by Section m.H;

    12. a description ofHSM's corporate structure, including identification ofany individual owners and investors, parent and sister companies, subsidiaries, affiliates, and their respective lines ofbusiness, and landlords;

    13. a list ofall ofHSM's locations (including locations and mailing addresses), the corresponding name under which each location is doing business, and the location's Medicare and state Medicaid program provider number and/or supplier number(s); and

    31 HSMCIA

  • 14. the certifications required by Section V.C.

    B. Annual Reports. HSM shall submit to OIG a report on its compliance with the CIA requirements for each of the five Reporting Periods (Annual Report).

    Each Annual Report shall include, at a minimum, the following information:

    1. any change in the identity, position description, or other noncompliance job responsibilities ofthe Compliance Officer, a current list of the Compliance Committee members, a current list ofBoard members who are responsible for sastisfying the Board ofDirectors compliance obligation, and a current list ofthe Certifying Employees, along with the identification ofany changes made during the Reporting Period to the Compliance Committee, Board ofDirectors, and Certifying Employees;

    2. the dates of each report made by the Compliance Officer to the Board (written documentation of such reports shall be made available to OIG upon request);

    3. a summary ofactivities and findings under HSM's Quality of Care Review Program and a summary of any corrective action taken in response to any problems identified through its Quality of Care Review Program as required by Section ill.A.2.c;

    4. a summary of the Compliance Committee's measurement, analysis, and tracking of the performance metrics included in HSM's Dashboard, HSM's progress towards its quality improvement goals, and any changes to the Dashboard and the reasons for such changes, and activities, assessments, recommendations, and findings related to staffing and HSM' s response to those findings;

    5. the Board resolution required by Section m.A.3 and a description of the documents and other materials reviewed by the Board, as well as any additional steps taken, in its oversight of the compliance program and in support ofmaking the resolution;

    6. a list of any new ofrevised Policies and Procedures developed during the Reporting Period;

    32 HSMCIA

  • 7. a description of any changes to HSM' s Training Plan developed pursuant to Section III.C and swnmary ofany Board ofDirectors training provided during the Reporting Period;

    8. HSM's response and action plan(s) related to any written recommendations of the Monitor pursuant to Section Ill.D;

    9. a summary of the disclosures in the disclosure log required by Section ill.E that relate to Federal health care programs and delivery ofresident care, including at least the following information: a description of the disclosure, the date the disclosure was received, the resolution of the disclosure, and date the disclosure was resolved (if applicable). The complete disclosure log shall be made available to OIG upon request;

    10. a summary ofReportable Events (as defined in Section ill.I) identified during the Reporting Period and the status of any corrective and preventative action relating to all such Reportable Events;

    11. a description ofany changes to the Ineligible Persons screening and removal process required by Section III.F,·including the reasons for such changes;

    12. a description of any changes to the Overpayment policies and procedures required by Section ID.H, including the reasons for such changes;

    13. a summary describing any ongoing investigation or legal proceeding required to have been reported pursuant to Section III.G. The summary shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding;

    16. a description of all changes to the most recently provided list ofHSM's locations as required by Section V.A.13; and

    17. the certifications required by Section V.C.

    The first Annual Report shall be received by OIG no later than 60 days after the end of the first Reporting Period. Subsequent Annual Reports shall be

    33 HSMCIA

  • received by OIG no later than the anniversary date ofthe due date of the first Annual Report.

    C. Certifications

    1. Certifying Employees. In each Annual Report, HSM shall include the certifications ofCertifying Employees as required by Section III.A.4;

    2. Compliance Officer and Chief Executive Officer. The Implementation Report and each Annual Report shall include a certification by the Compliance Officer and ChiefExecutive Officer that:

    a. to the best ofhis or her knowledge, except as otherwise described in the report, HSM has implemented and is in compliance with all of the requirements ofthis CIA; and

    b. he or she has reviewed the report and has made reasonable inquiry regarding its content and believes that the information in the report is accurate and truthful.

    D. Designation ofInformation. HSM shall clearly identify' any portions of its submissions that it believes are trade secrets, or information that is commercial or financial and privileged or confidential, and therefore potentially exempt from disclosure under the Freedom ofInformation Act (FOIA). 5 U.S.C. § 552. HSM shall refrain from identifying any information as exempt from disclosure if that information does not meet the criteria for exemption from disclosure .under FOIA.

    VI. NOTIFICATIONS AND SUBMISSION OF REPORTS

    Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this CIA shall be submitted to the following entities:

    OIG: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General

    34 HSMCIA

  • U.S. Department ofHealth and Human Services Cohen Building, Room 5527 330 Independence Avenue, S.W. Washington, DC 20201 Telephone: 202.619.2078 Facsimile: 202.205.0604

    HSM: Chief Compliance Officer Health Services Management, Inc. Clo William H. Neely, Chief Legal Officer 206 Fortress Boulevard Murfreesboro, Tennessee 37128 Telephone: 615.896.1191 Facsimile: 615.890.7978

    Unless otherwise specified, all notifications and reports required by this CIA may be made by certified mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. For purposes of this requirement, internal facsimile confirmation sheets do not constitute proofof receipt. Upon request by OIG, HSM may be required to provide OIG with an electronic copy ofeach notification or report required by this CIA in searchable portable document format (pdf), in addition to a paper copy.

    VII. OIG INSPECTION. AUDIT. AND REVIEW RIGHTS

    In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies ofHSM's books, records, and other documents and supporting materials and conduct on-site reviews of any ofHSM's locations for the purpose ofverifying and evaluating: (a) HSM's compliance with the terms of this CIA; and (b) HSM's compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by HSM to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of HSM's owners, employees, contractors, or and directors who consent to be interviewed at the individual's place ofbusiness during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. HSM shall assist OIG or its duly authorized representative(s)

    35 HSMCIA

  • in contacting and arranging interv.iews with such individuals upon OIG's request. HSM's owners, employees, contractors, and directors may elect to be interviewed with or without a representative ofHSM present.

    VIII. DOCUMENT AND RECORD RETENTION

    HSM shall maintain for inspection all documents and records relating to reimbursement from the Federal health care programs and to compliance with this CIA, for six years (or longer ifotherwise required by law) from the Effective Date.

    IX. DISCLOSURES

    Consistentwith lffiS's FOIA procedures, set forth in 45 C.F.R Part 5, OIG shall make a reasonable effort to notify HSM prior to any release by OIG of information submitted by HSM pursuant to its obligations under this CIA and identified upon submission by HSM as trade secrets, or information that is commercial or financial and privileged or confidential, under the FOIA rules. With respect to such releases, HSM shall have the rights set forth at 45 C.F .R. § 5.6S(d).

    X. BREACH AND DEFAULT PROVISIONS

    HSM is expected to fully and timely comply with all of its CIA obligations.

    A. Specific Performance of CIA Provisions. The parties agree that, if OIG determines that HSM is failing to comply with a provision ofthis CIA, OIG may seek specific performance of that provision. OIG shall provide HSM with prompt written notification ofsuch determination. (This notification shall be referred to as the "Noncompliance Notice.") HSM shall have 30 days from receipt .of the Noncompliance Notice within which to either: (1) cure the alleged failure to comply; or (2) reply in writing that HSM disagrees with the deterriiinationrof noncompliance and request a hearing before an HHS Administrative Law Judge (ALJ), pursuant to the provisions set for in Section X.F of this CIA.

    B. Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, HSM and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as "Stipulated Penalties") in accordance with the following provisions.

    36 HSMCIA

  • 1. A Stipulated Penalty of$2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day HSM fails to establish, implement, or comply with any ofthe following obligations as described in Section ill:

    a. a Compliance Officer;

    b. a Compliance Committee;

    c. the Board ofDirectors compliance obligations;

    d. a Quality of Care Review Program;

    e. a Dashboard;

    f. the management certification obligations;

    g. written Policies and Procedures;

    h. the training and education ofCovered Persons and Board Members;

    i. retention ofa Monitor;

    J. a Disclosure Program;

    k. Ineligible Persons screening and removal requirements;

    L notification of Government investigations or legal proceedings;

    m. policies and procedures regarding the repayment of overpayments; and

    n. reporting ofReportable Events.

    2. A Stipulated Penalty of$2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day HSM fails to submit a complete Implementation Report, Annual Reports, or any certification to

    37 HSMCJA

  • OIG in accordance with the requirements of Section V by the deadlines for submission.

    3. A Stipulated Penalty of$1,500 for each day HSM fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date HSM fails to grant access.)

    4. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf ofHSM as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this.CIA.

    5. A Stipulated Penalty of$2,500 (which shall begin to accrue on the day after. the date the obligation became due) for each day HSM fails to pay a Monitor, as required in Section III.D.5.

    6. A Stipulated Penalty of $2,500 for each day HSM fails to comply fully and adequately with any of its obligations with respect to the Monitor, including but not limited to the obligation to adequately and timely respond to any written recommendation of the Monitor, as set forth in Section ID.D.6. OIG shall provide notice to HSM stating the specific grounds for its determination that HSM has failed to comply fully and adequately with the CIA obligation(s) at issue and steps HSM shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after HSM receives this notice from OIG of the failure to comply.) ·

    7. A Stipulated Penalty of $1,000 for each day HSM fails to comply fully and adequately with any obligation ofthis CIA. OIG shall provide notice to HSM stating the specific grounds for its determination that HSM has failed to comply fully and adequately with the CIA obli~tion(s) at issue and steps HSM shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after HSM receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-6 of this Section.

    C. Timely Written Requests for Extensions. HSM may, in advance of the due date, submit a timely written request for an extension of time to perform any act or file any notification or report required by this CIA. Notwithstanding any other provision in this Section, ifOIG grants the timely written request with

    38 HSMCIA

  • respect to an act, notification, or report, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until one day after HSM fails to meet the revised deadline set by OIG. Notwithstanding any other provision in this Section, ifOIG denies such a timely written request, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until three days after HSM receives OIG's written denial of such request or the original due date, whichever is later. A "timely written request" is defined as a request in writing received by OIG at least five days prior to the date by which any act is due to be performed or any notification or report is due to be filed.

    D. Payment of Stipulated Penalties

    1. Demand Letter. Upon a finding that HSM has failed to comply with any of the obligations described in Section X.B and after determining that Stipulated Penalties are appropriate, OIG shall notify HSM of: (a) HSM's failure to comply; and (b) OIG's exercise of its contractual right to demand payment of the Stipulated Penalties. (This notification shall be referred to as the "Demand Letter.")

    2. Response to Demand Letter. Within 10 days after the receipt of the Demand Letter, HSM shall either: (a) cure the breach to OIG's satisfaction and pay the applicable Stipulated Penalties; or (b) request a hearing before an lffiS Administrative Law Judge (ALJ) to dispute OIG's determination of noncompliance, pursuant to the agreed upon provisions set forth below in Section X.F. In the event HSM elects to request an ALJ hearing, the Stipulated Penalties shall continue to accrue until HSM cures, to OIG's satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two manners within the allowed time period shall be considered a material breach of this CIA and shall be grounds for exclusion under Section X.E.

    3. Form ofPayment. Payment of the Stipulated Penalties shall be made by electronic funds transfer to an account specified by OIG in the Demand Letter.

    4. Independence from Material Breach Determination. Except as set forth in Section X.E. l .d, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG's decision that HSM has materially breached this CIA, which decision shall be made at OIG's discretion and shall be governed by the provisions in Section X.E, below.

    39 HSMCJA

  • E. Exclusion for Material Breach of this CIA

    I. Definition ofMaterial Breach. A material breach of this CIA means:

    a. repeated violations or a flagrant violation of·any of the obligations under this CIA, including, but not limited to, the obligations addressed in Section X.A;

    b. a failure· by HSM to report a Reportable Event, take corrective action, or make the appropriate refunds, as required in Section III.I;

    c. a violation ofany obligation under this CIA that has a material impact on the quality of resident care;

    d. a failure to respond to a Noncompliance Notice concerning specific performance in accordance with Section X.A;

    e. a failure to respond to a Demand Letter concerning the payment ofStipulated Penalties in accordance with Section X.D; or

    f. a failure to retain, pay, or use the Monitor, or failure to respond to the recommendations of the Monitor, in accordance with Section ill.D.

    2. Notice ofMaterial Breach and Intent to Exclude. The parties agree that a material breach of this CIA by HSM constitutes an independent basis for HSM's exclusion from participation in the Federal health care programs. The length of the exclusion shall be in the OIG's discretion, but not more than five years per material breach. Upon a determination by OIG that HSM has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall notify HSM of: (a) HSM's material breach; and (b) OIG's intent to exercise its contractual right to impose exclusion. (This notification shall be referred to as the "Notice ofMaterial Breach and Intent to Exclude.") The exclusion may be directed at one or more ofHSM's facilities or corporate entities, depending upon the facts of the breach.

    40 HSMCIA

  • 3. Opportunity to Cure. HSM shall have 30 days from the date of receipt ofthe Notice ofMaterial Breach and Intent to Exclude to demonstrate to OIG's satisfaction that:

    a. the alleged material breach has been cured; or

    b. the alleged material breach cannot be cured within the 30-day period, but that: (i) HSM has begun to take action to cure the material breach; (ii) HSM is pursuing such action with due diligence; and (iii) HSM has provided to OIG a reasonable timetable for curing the material breach.

    4. Exclusion Letter. If, at the conclusion of the 30-day period, HSM fails to satisfy the requirements of Section X.E.3, OIG may exclude HSM from participation in the Federal health care programs. OIG shall notify HSM in writing of its determination to exclude HSM. (This letter shall be referred to as the "Exclusion LetteJ,".") Subject to the Dispute Resolution provisions in Section X.F, below, the exclusion shall go into eff~ct 30 days after the date ofHSM's receipt ofthe Exclusion Letter. The exclusion shall have national effect. Reinstatement to program participation is not automatic. After the end of the period ofexclusion, HSM may apply for reinstatement by submitting a written request for reinstatement in accordance with the provisions at 42 C.F .R. §§ 1001.3001-.3004.

    F. Dispute Resolution

    1. Review Rights. Upon OIG's delivery to HSM of its Noncompliance Notice, Demand Letter, or Exclusion Letter, and as an agreedupon contractual remedy for the resolution ofdisputes arising under this CIA, RSM shall be afforded certain review rights comparable to the ones that are provided in 42 U.S.C. § 1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the specific performance, Stipulated Penalties, or exclusion sought pursuant to this CIA. Specifically, OIG's determination to demand specific performance, payment of Stipulated Penalties, or seek exclusion shall be subject to review by an HHS ALJ and, in the event ofan appeal, the :EIBS Departmental Appeals Board (DAB), in a manner consistent with the provisions in 42 C.F.R § 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the request for a hearing involving specific performance or Stipulated Penalties shall be made within 10

    41 HSMCJA

    http:1005.2-1005.21

  • days after receipt of the Demand Letter and the request for a hearing involving exclusion shall be made within 25 days after receipt of the Exclusion Letter. The procedures relating to the filing ofa request for a hearing can be found at http://www.hhs.gov/dab/division/civil/procedures/divisionprocedures.html.

    2. Specific Performance Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code ofFederal Regulations, the only issues in a proceeding for specific performance ofCIA provisions shall be: .

    a. whether, at the time specified in the Noncompliance Notice, HSM was in full and timely compliance with the obligations ofthis CIA for which OIG seeks specific performance; and

    b. whether HSM failed to cure.

    HSM shall have the burden ofproving its full and timely compliance and the steps taken to cure the noncompliance, ifany. OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to specific performance. Ifthe ALJ agrees with OIG, HSM shall take the actions OIG deems necessary to cure within 20 days after the ALJ issues such a decision unless HSM requests review of the ALJ decision by the DAB. Ifthe ALJ decision is properly appealed to the DAB and the DAB upholds the determination ofOIG, HSM shall take the actions OIG deems necessary to cure within 20 days after the DAB issues its decision.

    3. Stipulated Penalties Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code ofFederal Regulations, the only issues in a proceeding for Stipulated Penalties under this CIA shall be: (a) whether HSM was in full and timely compliance with the obligations of this CIA for which OIG demands payment; and (b) the period of noncompliance. HSM shall have the burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if any. OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to Stipulated Penalties. If the ALJ agrees with OIG with regard to a finding ofa breach ofthis CIA and orders HSM to pay Stipulated Penalties, such Stipulated Penalties shall become due and payable 20 days after the ALJ issues such a decision unless HSM requests review of the ALJ decision by the DAB. If the ALJ decision is properly appealed to the DAB and the DAB upholds the determination ofOIG, the

    42 HSMCIA

    http://www.hhs.gov/dab/division/civil/procedures/divisionprocedures.html

  • Stipulated Penalties shall become due and payable 20 days after the DAB issues its decision.

    4. Exclusion Review. Notwithstanding any provision ofTitle 42 of the United States Code or Title 42 of the Code ofFederal Regulations, the only issues in a proceeding for exclusion based on a material breach ofthis CIA shall be whether HSM was in material breach ofthis CIA and, if so, whether:

    a. HSM cured such breach within 30 days of its receipt of the Notice ofMaterial Breach; or

    b. the alleged material breach could not have been cured within the 30-day period, but that, during the 30-day period following HSM's receipt ofthe Notice of Material Breach: (i) HSM had begun to take action to cure the material breach; (ii) HSM pursued such action with due diligence; and (iii) HSM provided to OIG a reasonable timetable for curing the material breach.

    For purposes ofthe exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, ifthe ALJ rules for HSM, only after a DAB decision in favor of OIG. HSM's·election of its contractual right to appeal to the DAB shall not abrogate OIG's authority to exclude HSM upon the issuance ofan ALJ's decision in favor ofOIG. Ifthe ALJ sustains the determination ofOIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that HSM may request review of the ALJ decision by the DAB. If the DAB fmds in favor ofOIG after an ALJ decision adverse to 010, the exclusion shall take effect 20 days after the DAB decision. HSM shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. Ifthe DAB fmds in favor ofHSM, HSM shall be reinstated effective on the date of the original exclusion.

    5. Finality ofDecision. The review by an ALJ or DAB provided for above shall not be considered to be an appeal right arising under any statutes or regulations. Consequently, the parties to this CIA agree that the DAB's decision (or the ALJ's decision ifnot appealed) shall be considered fmal for all pwposes under this CIA.

    43 HSMCIA

  • XI. EFFECTIVE AND BINDING AGREEMENT

    . HSM and OIG agree as follows:

    A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.

    B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.

    C. OIG may agree to a suspension ofHSM's obligations under this CIA based on a certification by HSM that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. § 1320a-3, in any entity that bills any Federal health care program. lfHSM is relieved of its CIA obligations, HSM shall be required to notify OIG in writing at least 30 days in advance ifHSM plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.

    D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) HSM's responsibility to follow all applicable Federal health care program requirements or (2) the-government's right to impose appropriate remedies for failure to follow applicable Federal health care program requirements.

    E. The undersigned HSM signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA.

    F. This CIA may be executed in counterparts, each of which constitutes an original and all ofwhich constitute one and the same CIA. Electronicallytransmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA.

    44 HSMCIA

  • ON BEHALF OF.HSM

    /James E. Bell/

    JAMES ERIC BELL DATE Chief Executive Office.

    .Health S,OVices Management, Inc. . /Sean McKenna/

    SEAN MCKENNA DATE

    Greenburg Traurig, LLP .

    Counsel for Health Services Management, Inc.

    . 45 HSMCJA

  • ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEAL TH AND HUMAN SERVICES

    /LisaM. Re/

    or/,-s) 1+ LISA M. RE DATE

    Assistant Inspector General for Legal Affairs

    Office of Inspector General

    U. S. Department of Health and Human Services

    /Ellen Slavin/

    ELLEN E. SLAVIN DATE

    Senior Counsel

    ·Office of Inspector General U.S. Department of Health and Human Services

    46 f!SAI CIA

    Structure BookmarksCORPORATE INTEGRITY AGREEMENT .BETWEEN THE .OFFICE OF INSPECTOR GENERAL .OF THE .DEPARTMENT OF HEALTH AND HUMAN SERVICES .AND HEALTH SERVICES MANAGEMENT, INC. I. PREAMBLE Health Services Management, Inc. (HSM) hereby enters into this Corporate Integrity Agreement (CIA) with the Office ofInspector General (OIG) ofthe United States Department ofHealth and Human Services (IUIS) to promote compliance with the statutes, regulations, and written directives ofMedicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(t)) (Federal health care program requirements). Contemporaneously with this CIA, HSM is entering into a Settlement Agreement wiII. II. II. TERM AND SCOPE OF THE CIA

    A. A. The period ofthe compliance obligations assumed by HSM under this CIA shall be five years from the effective date of this CIA. The "Effective Date" shall be the date on which the final signatory ofthis CIA executes this CIA. Each one-year period, beginning with the one-year period following the Effective Date, shall be referred to as a "Reporting Period."

    B. B. This CIA applies to any Texas long term care facility in which HSM and/or an HSM subsidiary has an ownership or control interest, as defined in 42

    U.S.C. U.S.C. U.S.C. § 1320a-3{a)(3), and any Texas long term care facility managed or operated by HSM and/or an HSM subsidiary.

    C. C. Sections VII, X, and XI shall expire no later than 120 days after OIG's receipt of: (1) HSM's final Annual Report; or (2) any additional materials submitted by HSM pursuant to OIG's request, whichever is later.

    D. For purposes ofthis CIA, the term "Covered Persons" includes: I. all owners, officers, directors, and employees ofHSM; HSMCIA 2. all owners, officers, directors, and employees ofany Texas long term care facility in which HSM and/or an HSM subsidiary has an ownership or control interest, as defined in 42 U.S.C. § 1320a-3(a)(3), and ofany Texas long term care facility managed or operated by HSM and/or an HSM subsidiary at any time during the term ofthe CIA; and 3. all contractors, subcontractors, agents, and other persons who: (1) are involved directly or indirectly in the delivery ofresident care; (2) make assessments ofresidents that affect treatment decisions or reimbursement; (3) · perform billing, coding, audit, or review functions; ( 4) make decisions or provide oversight about staffing, resident care, reimbursement, policies and procedures, or this CIA; or (5) perform any function that relates to or is covered by this CIA, including individuals who are responsible for quality assurance, setting policies or procedures, or mAny nonemployee private caregivers and/or attending physicians hired by any resident or the family or friends ofany resident ofHSM are not Covered Persons, regardless ofthe hours worked per year in HSM. ill. CORPORATE INTEGRITY OBLIGATIONS . HSM shall establish and maintain a Compliance Program that includes the following elements: A. Compliance Officer and Committee. Board ofDirectors. and Management Compliance Obligations 1. Compliance Officer. Within 90 days after the Effective Date, HSM shall appoint a Compliance Officer and shall maintain a Compliance Officer for the term ofthe CIA. The Compliance Officer must have sufficient compliance and quality assurance experience to effectively oversee the implementation ofthe requirements ofthis CIA. The Compliance Officer shall be an employee and a member ofsenior management ofHSM, shall report directly to the Chief Executive Officer ofHSM, and shall not be or be subordinate to tha. .a. .a. .developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and professionally recognized standards ofcare;

    b. .b. .making periodic (at least quarterly) reports regarding compliance matters directly to the Board ofDirectors of HSM, and shall be authorized to report on such matters to the Board ofDirectors at any time. Written documentation ofthe Compliance Officer's reports to the Board ofDirectors shall be made available to OIG upon request; and

    c. .c. .monitoring the day-to-day compliance activities engaged in by HSM and any reporting obligations created under this CIA, and ensuring that HSM is appropriately identifying and correcting quality ofcare problems.

    Any noncompliance job responsibilities ofthe Compliance Officer shall be limited and must not interfere with the Compliance Officer's ability to perform the duties outlined in this CIA. HSM shall report to OIG, in writing, any changes in the identity ofthe Compliance Officer, or any actions or changes that would affect the Compliance Officer's ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change. 2. Compliance Committee. Within 90 days after the Effective Date, HSM shall appoint a Compliance Committee. a. .General Responsibilities. This committee shall support the Compliance Officer in fulfilling his/her responsibilities ~developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and professionally recognized standards ofcare; monitoring the day-to-day compliance activities engaged in by HSM; monitoring any reporting obligations created under this CIA; and ensuring that a. .General Responsibilities. This committee shall support the Compliance Officer in fulfilling his/her responsibilities ~developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA, Federal health care program requirements, and professionally recognized standards ofcare; monitoring the day-to-day compliance activities engaged in by HSM; monitoring any reporting obligations created under this CIA; and ensuring that HSM is appropriately identifying and correcting

    quality ofcare problems). The Compliance Committee shall, at a minimum, include the Compliance Officer and other members ofsenior management necessary to meet the requirements of this CIA( e.g., representatives from among senior personnel responsible for clinical operations and quality ofcare, human resources, operations). The Compliance Officer shall chair the Compliance Committee. The Compliance Committee shall meet, at a minimum, eve